Product code IXX— Radiology

AP-6CR CINERADIOGRAPHIC FILM PROCESSOR

Classification name
Processor, Cine Film
Device class
Class 2
Regulation
21 CFR 892.1900
Advisory panel
Radiology
Total cleared
6
First cleared
Most recent

Market context for product code IXX

FDA has cleared 6 devices under product code IXX between 1984 and 1996, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code IXX

Recent clearances under product code IXX

Data sourced from openFDA. This site is unofficial and independent of the FDA.